Single chamber intracardiac balloon pump

ABSTRACT

A method, apparatus and computer system product for improving cardiac output from the heart is presented. A balloon is placed within a chamber of a heart wherein the balloon encloses a mechanical expansion device and air. During a first time epoch in which the heart chamber is volumetrically contracting (during emptying), a mechanical expansion device causes the balloon to increase in size, which improves ejection fraction. During a second time epoch in which the heart chamber is volumetrically expanding (during filling), the mechanical expansion device causes the balloon to decrease in size, which improves filling.

CROSS REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/439,972 filed on Jun. 13, 2019.

TECHNICAL FIELD

Aspects of the present disclosure are generally related to medicine andmore specifically heart failure.

BACKGROUND

Heart failure is a medical condition where the heart does not adequatelypump blood to the organs of the body. One of the common causes ismyocardial infarction (also known as heart attack) from coronary arterydisease (narrowing of the blood vessels to the heart). During amyocardial infarction, a portion of the heart muscle dies off and theremaining heart muscle is overworked and progressively stretches outover time. The heart can enlarge and result in poor pumping ability.Coronary artery disease and myocardial infarction is just one of themany causes of heart failure. Other causes include high blood pressure,problems with heart valves, problems of the heart muscle (e.g., viralmyocarditis, amyloidosis, HIV, arrythmia, sarcoidosis, etc.) and manyothers.

If there is right heart failure (due to pathology of the right atriumand right ventricle), then blood can back up into the organs of the bodyand patients can suffer from swelling in the legs. If there is leftheart failure (due to pathology of the left atrium and left ventricle),then blood can back up into the lungs and patients can suffer fromsevere shortness of breath. Ultimately, depending on the cause, theheart failure may progress (i.e., pump failure worsens) and thecondition can be lethal.

A left ventricular assist device (LVAD) is a battery-operated mechanicalpump placed via an open-heart surgery procedure to treat end stage heartfailure patients who are awaiting a heart transplant. The LVAD pullsblood from the left ventricle and sends it to the aorta, which then goesto the rest of the body. There are several limitations of the LVAD.First, the LVAD works as a pump only to support the left ventricle.Thus, other heart chambers are not supported. Second, it requires majoropen-heart surgery, which carries significant risks. Third, it requiresa tube exiting the patient's skin connecting internal hardware toexternal hardware outside of the body. Thus, there are a set ofchallenges associated with the LVAD maintenance. Given theselimitations, a better method and apparatus is needed to support patientswho suffer from heart failure.

SUMMARY

All examples, aspects and features mentioned in this document can becombined in any technically possible way.

In accordance with an aspect of the invention a method comprises:inserting an intra-cardiac device component (for example, but notlimited to an intra-cardiac device component for expansion/contraction)into each of the chambers of the heart. The intra-cardiac devicecomponent in the right atrium and left atrium would be expanding whilethe tricuspid and mitral valves are open during the first-time epoch.The intra-cardiac device component expansion in the right atrium andleft atriums would push an increased flow of blood from these atriumsinto their respective ventricles. The intra-cardiac device component inthe right ventricle and left ventricle would be contracting at this timeepoch and the pulmonary and aortic valves are closed. Conversely, in thesucceeding time epoch, the intra-cardiac device component in the rightatrium and left atriums would be contracting while the tricuspid andmitral valves are closed. The intra-cardiac device component in theright ventricle and left ventricle would be expanding at this time epochand the pulmonary and aortic valves open. This sequence would increaseblood flow into pulmonary artery and aorta. The intra-cardiac devicecomponent would alternate expansion and contraction in successive epochsin accordance with the heart beats and functions of their respectivechambers. The intra-cardiac device component would be emplaced in one tofour chambers of the heart.

Some implementations comprise elements which include, but are notlimited to, the following: intra-cardiac device component (ICDC);pressurized fluid bottle which stores fluid and passes it thru a tubularsystem to cause the ICDC to expand when fluid is inserted and contractwhen fluid is released; in/out tubes for pressurized fluid with valvesto open/close to let air to enter ICDC or be released; storage elementfor the pressurized fluid; control mechanism which includes, but is notlimited to: pressure gauge for tubes; computed system with algorithm fortiming of the fluid/air input/output valve(s) to open/close duringemptying (i.e., ejection phase) of blood from chamber(s) based oncollected data (e.g., pressure, volume, rate, etc.); computer systemwith algorithm for timing of the fluid/air input/output valve(s) toopen/close during filling of blood into the chamber(s) based oncollected data (e.g., pressure, volume, rate, etc.); and power sourcepreferably internal in the chest wall subcutaneous fat (note: if thesystem controller and power source are external to the body, theseelements could be connected to local commercial power with a batterybackup). In further implementation, desired ejection parameters (e.g.,stroke volume, ejection fraction, etc.) could be modified by theintracardiac pump by analysis of multiple factors including but notlimited to the following factors: valve opening size; duration ofopening; and, heart chamber size.

Some implementations comprise a method to implant the ICDC andassociated tubing including, but is not limited to, the following:entering the device into the body in proximity to and into Superior VenaCava (SVC) and then following SVC to enter Right Atrium (RA); ICDC set 1(IS1) is then inserted thru the inter-atrial septum separating the RAand Left Atrium (LA) such that: one ICDC would be in LA, one in the RAand ICDC connector in the inter-atrial septum; ICDC set 2 (IS2) is theninserted thru the RA and into Right Ventricle (RV) and moved to aposition such that: ICDC set 2 could be inserted thru theinter-ventricular septum separating the RV and Left Ventricle (LV); oneICDC would be in RV, one in the LV and ICDC connector in theinter-ventricular septum. In continued implementation: connector tube(s)locations would include options: between the connectors of IS1 and IS2;between the connector of IS1 and external (or internal) fluid storagesource; and between the connector of IS2 external (or internal) fluidstorage source.

Some implementations comprise addition of one or more electrodestogether with the afore described set of components. The purpose ofthese electrodes would be to stimulate and synchronize heart functioningin concert with the ICDC components. The rate of stimulation by theelectrodes could be variable depending on the activity level of thepatient.

Some implementations comprise a variation in the location of systemelements. Example locations include, but are not limited to, thefollowing: internal to the body as a self-contained unit, but withprovision to replace power source; and ICDC internal to body andconnector tubing and wiring both internal and external internal to thebody and controller, fluid storage element and power source external tothe body. In further implementation, if pressurized gas (e.g., air) isused as the mechanism to cause the ICDC to expand and the gas releasedwhen contraction occurs, a pressurized gas bottle could hold the gasexternal to the body and periodically be replaced when the stored gaswas expended. If the fluid used as the mechanism to cause the ICDC toexpand/contract is a liquid (e.g., saline solution), the fluid could bestored within a closed system.

Some implementations comprise a mechanism, other than fluid pressuredifferential, the cause the ICDC which include, but are not limited to,the following: for a closed system, a magnetized piston within thetubular system could connect the ICDC for right atrium (RA) and leftatrium (LA) and the ICDC for right ventricle (RV) and left ventricle(LV) which would alternate electric current flow between magnets on thetubular system and permanent magnet on the piston. Current is providedalternating between magnets on the tubing and in synchronization withthe heartbeat. Thus, the movement of the piston would push fluid intoone ICDC and extract from the other during one-time epoch and reversedduring the succeeding time epoch.

Some implementations comprise a mechanism, other than the ICDC toincrease the blood flow out of the LV. This would include, but is notlimited to, the following: a piston within a cylindrical-type shapedtube that is open at one end located within the LV. During the epochswherein blood was entering the LV from the LA, the piston would be nearthe base of the cylinder. And, during the ejection epoch the pistonwould move forward toward the open end of the cylinder, thus pushing outthe blood in the cylinder, thereby contributing to the volume of bloodejected during this time epoch. Further implementation could include,but is not limited to, the following: alternate electric current flowbetween magnets on the near ends of the cylinder and permanent magnet onthe piston. Current is provided alternating between magnets on thecylinder in synchronization with the heartbeat. This option wouldobviate the need for external/internal storage of fluid.

Some implementations comprise a method to work in conjunction with apacemaker, in present within the patient. The method includes, but isnot limited to, the following: the signal emitted by the pacemaker couldbe detected by a sensor within the system and communicated to thecontroller element. The controller would then, in turn, synchronize theexpansion/contraction of the ICDC accordingly. Note that without apacemaker, the system controller would provide timing for the epochs ofthe expansion/contraction of the ICDCs.

Some implementations comprise a method to work in conjunction with apressure sensor within the ICDC elements. The method includes, but isnot limited to, the following: including a pressure sensor within theICDC to sensing pressure and pressure changes within the chambers. Thisinformation would be transmitted to the controller and could be used totrigger expansion or contraction of the ICDC. The pressure data wouldalso be available for diagnostic purposes.

Some implementations comprise a method to work in conjunction with avalve prosthesis within the heart. The ICDC in associated with the valveprosthesis to achieve coordinated movements during the valve prosthesispositioning. This method includes, but is not limited to, the following:mechanical connection between the ICDC and the valve prosthesis;electrical connection between the ICDC and the valve prosthesis; and,sensor system within the ICDC to detect the prosthetic valve position.Note: the ICDC may work in a similar fashion with a native heart valveto achieve synchronized movements.

Some implementations comprise a method to provide two (or more) levelsof pressure for the ICDC. An example of a two levels of pressure systemincludes, but not limited to, the following: system could have ahigh-pressure element for the LV and a low-pressure element for the RA,LA, and RV. Separate tubing would pass the fluid of these two differentpressure levels from their storage elements (i.e., high and lowpressures) to respective ICDCs. This would accommodate approximate orderof magnitude difference in pressure between these chambers.

Some implementations comprise a method to control the timing of theepochs. The duration of the epochs can be controlled by the controllerelement with manual input from the patient. Variables which could affectthe timing include, but are not limited to, the following: the patient'sactivity level with a decrease in the time interval of an epochcorresponding to an increase in activity level; a selected epochinterval between activation of ICDC (e.g., on for two epochs and off fortwo epochs).

Some implementations comprise a method to provide a pre-installationplanning process. From a ‘systems’ perspective, the volume of bloodejected from each of the chambers should be roughly equal (assumingthere are no shunts). As an example, the total blood flow through thebody could be limited due to the low ejection from the LV while the RA,RV, and LA might capable of increased blood volume flow. In this examplescenario, the LV is the “rate-limiting step” for the flow to the wholebody. With this stipulation, the pre-installation process could include,but is not limited to, the following: the pre-existing ejectionparameters (e.g., end diastolic volume, end systolic volume, ejectionfraction, etc.) can be calculated during an echocardiogram (or otherimaging procedure) while examining heart functioning. Based on the sizeof the chamber, the current level of volume ejection for each chamber,the desired level of ejection, the size of the ICDC can be calculated toachieve the desired level of extraction as compared with the currentlevel of ejection. This, in turn, would determine the size of the ICDCand the fluid flow rate into the ICDC.

Some implementations comprise a method to provide a check on systemoperation. This would include, but is not limited to, the following: thesystem could include an ultrasound monitor which would perform thefunction of performing an echo calculation of ejection volume for eachchamber after installation and during operation of the system. Thismonitor could be linked to the system controller and adjustments, asnecessary, in ICDC size for each chamber could be calculated and thecontrol system would implement these needed adjustments.

Some implementations comprise a method to provide a capability withinthe system controller to generate a report regarding utilization of thesystem over the reporting period. Reporting elements could include, butare not limited to, the following: the report could: indicate ICDC sizeduring each epoch for each chamber: associated ejection parameters(e.g., end systolic volume, end diastolic volume, ejection fraction,etc.) for each chamber for each epoch; and number of epochs; totalejection volume during the reporting period; and statistics regardingthese measures. If pressure readings within the chambers were available,these could be included in the report. This information could becorrelated with the patient's health and progress on metrics such asexercise performance. As the patient's overall health improves, thedevice parameters (e.g., ICDC size) for each epoch health could beadjusted.

BRIEF DESCRIPTION OF FIGURES

FIG. 1 illustrates oxygenated blood flowing into left ventricle assistedby an intra-cardiac device component.

FIG. 2 illustrates the intra-cardiac device component functioning duringblood ejection from ventricles.

FIG. 3 illustrates the intra-cardiac device component functioning duringblood ejection from atria.

FIG. 4 illustrates an implementation of the intra-cardiac pump systemcomponents.

FIG. 5 illustrates the intra-cardiac device component (ICDC)sub-elements.

FIG. 6 illustrates the intra-cardiac device component volume duringexpansion/contraction phases and internal pressure.

FIG. 7 illustrates the intra-cardiac device component requirements.

FIG. 8 illustrates overall intra-cardiac pump system components.

FIG. 9 illustrates an overview of the clinical setting, placement of thedevice and the follow up period.

FIG. 10 illustrates an overview of the preferred method of placement ofthe ICDC.

FIG. 11 illustrates the heart and arteries with respective pressuresduring expansion and contraction.

FIG. 12 illustrates a system wherein some of the fluid is shifted backand forth from the atrial components of the ICDC to the ventricularcomponents of the ICDC.

FIG. 13 illustrates an ICDC system with the addition of electrodes tostimulate heart function and an artificial valve.

FIG. 14 illustrates the device which could be placed through a singlepuncture through the interventricular septum and yield intracardiacpumps into each atrium and each ventricle.

FIG. 15 illustrates an implementation that could be placed through asingle puncture through the interventricular septum and yield ICDCs intoeach atrium and each ventricle.

FIG. 16 illustrates an example ICDC device wherein the pressure insidethe device decreases while the ICDC is expanding.

FIG. 17 quantifies volumetric displacement by an ICDC duringexpansion/contraction phases and internal pressure.

FIG. 18 illustrates a simplified system containing only a leftventricular ICDC without a reservoir.

DETAILED DESCRIPTION OF FIGURES

FIG. 1 illustrates oxygenated blood flowing into the left ventricle 208during contraction of the left atrium 206 with the mitral valve 222open, thereby allowing oxygenated blood 226 to flow into the leftventricle 208 which is expanding during this part of the cycle. Theaortic valve 224 is closed at this instant. An intra-cardiac deviceincluding an atrial component 102 and a ventricular component 104facilitates the flow of the oxygenated blood 226 by volumetricdisplacement. The atrial intra-cardiac device component (ICDC) 102within the left atrium 206 expands (increases in volume) when the leftatrium 206 is emptying/contracting. The ventricular ICDC 104 contracts(decreases in volume) when the left ventricle 208 is filling/relaxing.During the next part of the cycle, the expansion/contraction process isreversed, i.e., the left atrium 206 is expanding and left ventricle 208is shrinking. In this next part of the cycle the aortic valve 224 wouldthen be open, thereby allowing oxygenated blood 226 to flow to the bodyand the mitral valve 222 would be shut. Similar expansion/contractionoccurs in the right atrium and right ventricle and with their respectivevalves. Thus, the ICDCs support the heart in both the filling andemptying phases by volumetric displacement of blood viaexpansion/contraction.

FIG. 2 illustrates the ICDCs 102, 104 functioning during blood ejectionfrom ventricles. The ventricular ICDC 104 expands when the rightventricle 204 and left ventricle 208 are emptying/contracting. Theventricular ICDC 104 is expanding in the right ventricle 204 pushingdeoxygenated blood 228 through the pulmonary valve 220 into thepulmonary artery 214. Concurrently, the ventricular ICDC 104 is pushingoxygenated blood 226 from the left ventricle 208 through the aorticvalve 224 into the aorta 212. The tricuspid valve 218 is closed. Themitral valve 222 is also closed. During this time, the atrial ICDC 102shrinks, which helps deoxygenated blood 228 flow from the inferior venacava and superior vena cava 210 into the relaxing right atrium 202 andoxygenated blood 226 flow from the pulmonary veins 216 into the relaxingleft atrium 206. Not all chambers in the heart are the same size andshape so each ICDC may be specially designed for that chamber, e.g. witha specific volume displacement due to expansion and contraction.

FIG. 3 illustrates the ICDCs functioning during blood ejection fromatria. This epoch of heart functioning follows the epoch described inFIG. 2. The atrial ICDC 102 expands when the right atrium 202 and leftatrium 208 are emptying. The ventricular ICDC 104 shrinks when the rightventricle 204 and left ventricle 208 are filling. The ICDCs can becomprised of different materials, shapes and sizes. For illustrativepurposes, the atrial ICDC 102 is shown with a balloon-type design andthe ventricle ICDC 104 is shown with a piston-cylinder-type design. Thetricuspid valve 218 is open allowing deoxygenated blood 228 to flow fromthe right atrium 202 to the right ventricle 204. The pulmonary valve 220is closed. The mitral valve 222 is open so that oxygenated blood 226 canflow from the left atrium 206 to the left ventricle 208. The pulmonaryvalve 220 and aortic valve 224 are closed during this epoch.

FIG. 4 illustrates an implementation of a piston-cylinder-type ICDC 100in greater detail. A battery pack 400 provides power for the system. Acomputer/control system 402, which can be an intra-cardiac or external(e.g., subcutaneous chest wall) programmable device provides timing forthe ICDC 100. These computer/control system 402 commands can betransmitted to the ICDC through the electrical connection 404 or viawireless system. The right portion of the figure shows a fluid storagedevice 406 (e.g., compressed air, non-compressible fluid). The fluidflows from the storage device to the ICDC 100 via tubing 408 (i.e., madeof non-compliant materials). Also shown is a penetrator device 410,which is designed to perforate (i.e., create a small hole) theinter-atrial septum or the interventricular septum for device placement.Variations to this system layout include whether key components areinternal or external to the body. Note that the ICDC 100 has multiplesub-elements that will be described below in FIG. 7, including: externalcasing sub-element; internal support structure; volumeexpansion/shrinkage sub-element; internal medium sub-element; heartfixation sub-element; sensor components; and, control components.

FIG. 5 illustrates sub-elements of a balloon-design-type ICDC in greaterdetail. The tubing for passage of fluids 408 (e.g., compressed air)joins the sub-component of the ICDC that traverses the interatrialseptum or interventricular septum. Two balloons 500 are connected by thesub-components 502 of the ICDC that affixes to the interatrial septum orintraventricular septum. The balloon sub-components 500 of the ICDCexpand and contract to displace blood to assist with heart pumping.These balloons 500 are located in either left and right atriums or leftand right ventricles or both. As noted on the figure, although twoballoons 500 are shown, the expansion/contraction sub-elements couldinclude, but are not limited to, a cylinder with internal piston orsimilar device which would allow for expansion to push blood out of thechamber or contraction to allow flow of blood into the chamber. Aballoon 500 volume expansion/contraction sub-element in rightatrium/ventricle encloses internal medium sub-element. The ICDC cantransmit or receive via the electrical connection 404 or wirelesscommunication. A sub-component of the ICDC 100 would traverse throughthe wall separating the respective chambers (interatrial septum orinterventricular septum). Heart fixation sub-elements 502 ontointer-atrial septum or inter-ventricular septum. External casingsub-element encloses internal support structure and houses sensorcomponents and control components.

FIG. 6 quantifies volumetric displacement by an ICDC 100 duringexpansion/contraction phases and internal pressure. Specifically,volumes and pressures within the ICDC are shown as a function ofexpansion (i.e., enlarging) and contraction (i.e., shrinking). Thevolumes and pressures shown are merely illustrative and would varydepending on the patient.

FIG. 7 illustrates ICDC functions and requirements. Although the figureis self-explanatory, it is important to note the design flexibility. Forexample, a wide range of non-toxic materials could be used for the ICDC.Similarly, different mechanisms could be used to displace volumes ofblood via expansion/contraction or decompression/compression. There aremultiple sub-elements of the ICDC including: an external casingsub-element 700; an internal medium sub-element 702; a volumeexpansion/shrinking sub-element 704; an internal support structuresub-element 706; and, a heart-fixation sub-element 708. The externalcasing sub-element 700 has specific design requirements 710. Since theexternal casing material contacts the heart and blood, it should meet astringent set of requirements including, but not limited to, thefollowing: durable; air-tight; fluid-tight; non-toxic; and, smoothedges. Materials may include but are not limited to the following:metal(s); non-metal(s); plastic(s); synthetic(s); autograft(s); and,allograft(s). The internal medium sub-element 702 may have specificdesign requirements 712. The internal medium nominally consists ofeither: a compressible gas to allow for increasing/decreasing volume ofthe ICDC; or, a non-compressible fluid with reservoir located outside ofthe heart chamber. The volume expansion/shrinking sub-element 704 hasspecific design requirements 714. The volume expansion/shrinkingsub-element is performed in synchrony with emptying/filling of cardiacchamber. The materials may include, but are not limited to: balloon;spring; piston; etc. The internal support structure sub-element 706 mayhave specific design requirements 716. The internal support structuresub-element provides the following: fixation of the volumeexpansion/shrinkage sub-element to the heart fixation sub-element;houses sensor sub-element; and, houses control sub-element. The heartfixation sub-element 708 has specific design requirements 718. Theheart-fixation sub-element provides attachment of the heart device tothe heart (e.g., fibrous portion of the interventricular septum).

FIG. 8 illustrates overall system components. The overall system 800 hasmultiple elements: intra-cardiac device component 100; control device804; battery pack 806; penetrator device 808; communications system 810;hose 812; and, if applicable, cardiac valve(s) 814. The ICDC 100function 816 is to perform continuous cycling of shrinking and expansion816. The control device 804 (e.g., electrical device in the subcutaneousfat of the chest wall) function 818 is to control the ICDC parameters(e.g., rate and volume of expansion/contraction, etc.) in accordancewith the heart rhythm monitoring. The battery back 806 (e.g., battery isincluded in the casing of the device in the subcutaneous fat of thechest wall) function 806 is to supply power to both the electricaldevice in the chest wall and the ICDC 820. The battery pack may beincluded in the same external casing as the electrical device of thechest wall or separate for easier exchange. The penetrator device 808function 822 is to puncture through the inter-atrial septum orinter-ventricular septum. The penetrator device 808 can be made ofvarious materials (e.g., metal or non-metal), shapes (e.g., of varyingsharpness), etc. The penetrator device 808 may be single use only at thetime of placement of the ICDC. The communication system 810 function 824is to provide transfer of power and information amongst elements of theintra-cardiac pump overall system. Note that a wireless communicationssystem 810 may also be implemented. The hose sub-element 812 has thefunction 826 of performing transfer of gas or other fluid to allow theICDC to expand or contract. Note that the gas or fluid can betransferred from outside to the heart to inside the heart during theexpansion phase of the ICDC. Alternatively, the gas or fluid can betransferred from the ICDC component in one chamber to the ICDC componentin another chamber. The hose 812 can be made of materials including, butnot limited to, noncompliant materials including plastic, rubber,Gore-Tex®, etc. Additionally, it is possible to integrate cardiacvalve(s) 814 into this overall system, such that the ICDC 100 works inconjunction with the cardiac valve 814 function 828 of cycles ofopenings and closings.

FIG. 9 illustrates an overview of the clinical setting, placement of thedevice and the follow up period. This figure places in context theprocess under which the patient would be treated. Of importance is thepre-planning that must be done regarding internal placement of ICDCs.Note also there is considerable flexibility in the number ofexpansion/contraction devices emplaced in the heart which could rangefrom one chamber to all four chambers. Note also that during the periodclosely following the emplacement of the intra-cardiac devicecomponents, there is a clinical review and adjustments made to thetiming and volumetric expansion/contraction as required. The first step900 is to perform pre-operative assessment including patient history(e.g., shortness of breath), physical examination (e.g., jugular venousdistention), laboratory assessment (e.g., elevated cardiac markers),pre-operative imaging (e.g., echocardiogram) and diagnosis (e.g., leftheart failure with ejection fraction of 20%). The heart rhythm andprecise timing of the contractions of the right atrium, left atrium,right ventricle and left ventricle is precisely characterized. Thesecond step 902 is to select the specific intra-cardiac device component(e.g., single ventricle vs dual ventricle vs atria-ventriclecombination; volume capacity, material, etc.) as well as the supportingequipment as described in FIG. 8. The third step 904 is to performpre-surgical planning session(s) (e.g., determine whether it beendovascular or open procedure; key anatomical landmarks noted; etc.).The fourth step 906 is the placement of the ICDC and accessories. Also,the staff will perform initial monitoring, adjust the device (orreplaced as clinically indicated), etc. The fifth, and final, step 908is to perform routine follow up wherein the device adjusted or replacedas clinically indicated.

FIG. 10 illustrates an overview of a method of placement of the ICDCendovascularly through the venous side with the preferred venous accesssite being the jugular vein. The first step 1000 is a needle puncture inthe jugular vein, dilation of the tract, vascular cut-down as needed andplacement of a large sheath into the jugular vein and then into thesuperior vena cava. There are multiple paths by which the intra-cardiacdevice expansion/contraction component(s) can be place into the heart.Alternatively, this could be placed through femoral vein access. Thesecond step 1002 is placing the ICDC with associated leads/tubes throughthe sheath, traversing through the superior vena cava, through the rightatrium and then into the right ventricle. The third step 1004 is underimage guidance, a small hole is made through the fibrous portion of theinterventricular septum creating a small interventricular defect usingthe penetrator device. Then, the heart fixation device is placed to fixthe ICDC to the fibrous portion of the interventricular septum and allowtransfer of the internal fluid medium between the components of the ICDCin the right ventricle and the components of the ICDC in the leftventricle. The fourth step 1006 is for the left ventricular componentsof the ICDC to be placed through the newly created interventriculardefect into the left ventricle and the right ventricular components ofthe ICDC in the right ventricle. The fifth step 1008 is for the deviceto be secured in place to the heart in a manner which the createdintraventricular defect is sealed. The sixth step 1010 is to place thatlead such that it traverses from the ICDC into the right ventricle,right atrium, superior vena cava and jugular vein and connects to theelectrical control device in the chest wall. The electrical activity ofthe heart is monitored and the ICDC begins pumping in a synchronous modeto assist the heart and improve the ejection fraction to the optimumlevel. After device is placed, the operator will perform an assessment,revise as necessary, and perform standard venous/skin closure proceduresare performed.

FIG. 11 illustrates the heart and arteries with respective pressuresduring expansion and contraction. A wire 404 is shown passing from thesuperior vena cava into the right atrium 202 through the tricuspid valve204 and to the ICDC device 100 positioned at the fibrous portion of theinterventricular septum with a balloon component 500 located in theright ventricle 204 and left ventricle 208. Also shown is a tableillustrating the goal pressures in the heart chambers and exitingarteries. Note the near order of magnitude differences in pressuresbetween left ventricle (LV)/aorta and other chambers in the heart. Thishigher pressure is obtained by the strong muscular structure of the leftventricle 208. Also note that when a patient has a myocardialinfarction, some of this muscular tissue may be damaged resulting in aloss of the cardiac output. This loss is compensated by theexpansion/contraction element 500 of the ICDC 100. This may help theleft ventricle recover function over time. The volumes of theexpansion/compression elements 500 located in left ventricle 208 andright ventricle 204 can be the same or vary slightly different asdesired by the physician. This illustrates that the specific sizes ofthese elements will be determined based on the specific heart structureand condition of the patient at hand. An alternative setup would be tohave a single fluid storage source 1100 located in the right atrium 202.Another alternative setup would be to have a fluid storage source 1100located in the right atrium and a fluid storage source located in theleft atrium 1102. The fluid storage sources could be affixed to theatria by securing devices 1104. This setup would allow endovascularplacement of all structures connected in a single device since allstructures are connected in a linear fashion.

FIG. 12 illustrates a system wherein some of the fluid is shifted backand forth from the atrial ICDC 102 to the ventricle ICDC 104. Thisillustration is in the time epoch wherein the left ventricle 208 isejecting oxygenated blood 226 into the aorta 212. A right atrialdisplacement sub-component 102 a of ICDC 102 shrinks (illustrated movingfrom large dashed line ellipse to smaller solid line ellipse), whichhelps pull deoxygenated blood 228 from the superior vena cava/inferiorvena cava 210 into the right atrium 202. A left atrial displacementsub-component 102 b of ICDC 102 shrinks (illustrated moving from largedashed line ellipse to smaller solid line ellipse), which helps pulloxygenated blood 226 from the pulmonary veins 216 into the left atrium206. A right ventricular displacement sub-component 104 a of the ICDC104 expands (illustrated moving from dashed line ellipse to larger solidline ellipse), which helps the right ventricle 204 to eject deoxygenatedblood 228 through the open pulmonic valve 220 into the pulmonary artery214. Note that the tricuspid valve 218 is closed during this time epoch.A left ventricular displacement sub-component 104 b of the ICDC 104expands (illustrated moving from dashed line ellipse to larger solidline ellipse), which helps the left ventricle 208 to eject oxygenatedblood 226 through the open aortic valve 224 into the aorta 212. Notethat the mitral valve 222 is closed during this time epoch. As theatrial displacement components of the ICDC 102 shrink, the fluid mediumtravels from the atrial displacement components of the ICDC to the hose1200. The location of the hose 1200 can vary (e.g., course through anycombination of the right atrium 202, right ventricle 204, left atrium206, left ventricle 208, valves or myocardium). Also shown is the wire404 connecting the ICDC to the rest of the apparatus. Note that theballoon size, shape, material and other properties can be altered suchthat it is optimally designed for the cardiac chamber that it is placedin. The epoch illustrated in the figure has blood filling the atria andblood exiting the ventricles. This particular configuration stores thefluid within the intra-cardiac device expansion/contraction componentsshown and obviates the need for a fluid storage device (e.g., storedoutside the heart such as in the pleural space) and associated tubingfrom the fluid storage device. A sub-element within the cylinderconnecting the intra-cardiac device expansion/contraction componentswithin the atriums and those within the ventricles could have a piston(or other type of sub-element) that pulls fluid from the atriumintra-cardiac device expansion/contraction components and pushes thefluid into the ventricle intra-cardiac device expansion/contractioncomponents. This process would be reversed during the following epoch ofheart functioning.

FIG. 13 illustrates an ICDC system with the addition of electrodes tostimulate heart function and an artificial valve. This illustration isin the time epoch wherein the left ventricle 208 is ejecting oxygenatedblood 226 into the aorta 212. The right atrial displacementsub-component 102 a of the ICDC 102 shrinks (illustrated moving fromlarge dashed line ellipse to smaller solid line ellipse), which helpspull deoxygenated blood 228 from the superior vena cava/inferior venacava 210 into the right atrium 202. The left atrial displacementsub-component 102 b of the ICDC 102 shrinks (illustrated moving fromlarge dashed line ellipse to smaller solid line ellipse), which helpspull oxygenated blood 226 from the pulmonary veins 216 into the leftatrium 206. The right ventricular displacement sub-component 104 a ofthe ICDC 104 expands (illustrated moving from dashed line ellipse tolarger solid line ellipse), which helps the right ventricle 204 to ejectdeoxygenated blood 228 through the open pulmonic valve into thepulmonary artery 214. Note that the tricuspid valve 218 is closed duringthis time epoch. The left ventricular displacement sub-component 104 bof the ICDC 104 expands (illustrated moving from dashed line ellipse tolarger solid line ellipse), which helps the left ventricle 208 to ejectoxygenated blood 226 through the open aortic valve 224 into the aorta212. Note that the mitral valve 222 is closed during this time epoch. Asthe atrial displacement components of the ICDC 102 shrink, the fluidmedium travels from the atrial displacement components of the ICDC tothe hose 1200. The location of the hose 1200 can vary (e.g., coursethrough any combination of the right atrium 202, right ventricle 204,left atrium 206, left ventricle 208, valves or myocardium). Also shownis the wire 404 connecting the ICDC to the rest of the apparatus. Apossible design alternative is to incorporate electrodes to stimulatethe functioning of the heart. The electrodes and associated electricalconnection wiring 1300 to transmit electrical pulses is shown in red andcan be used to stimulate the right atrium 202, left atrium 206, rightventricle 204, left ventricle 208 or any combination thereof. Thecontrol component (not shown) would determine timing for transmittingthe electrical pulses. These pulses would, in turn, signalcontraction/relaxation of the chambers with corresponding valveopening/closing. Note also that artificial valves or other devices couldalso be incorporated into this overall apparatus. For example, anillustration of a mechanical mitral valve 1302 is shown.

FIG. 14 illustrates an implementation that could be placedendovascularly through a single puncture through the interventricularseptum and yield ICDCs into each atrium and each ventricle. Theelectrical control device 402 and battery 400 are connected to the ICDCsvia a wire 404. The wire 404 is attached to the right atrial ICDC fluidstorage device 1100, which is illustrated with a securing device 1104such that it can be secured to the right atrium. Both a wire 404 and afluid transport tube 408 extend from the right atrial ICDC fluid storagedevice 1100 to the right ventricular ICDC device 500. A fixation device100 which has been placed through the interventricular septum connectsthe right ventricular ICDC device 500 to the left ventricular ICDCdevice 500. The fixation device 100 contains the wire 404 and,optionally, a tube. The wire 404 and tube 408 extend from the leftventricular ICDC device 500 to the reservoir 1100 in the left atrium,where it can be attached to the left atrium via a fixation device 1104.Near the end of the tube, a penetrator device 410 can be included suchthat the device can be placed through the interventricular septum.Alternatively, the penetrating device 410 can be a separate piece ofequipment.

FIG. 15 illustrates an implementation that could be placed through asingle puncture through the interventricular septum and yield ICDCs intoeach atrium and each ventricle. The electrical control device 402 andbattery 400 are connected to the ICDCs via a wire 404. The wire 404 isattached to the right atrial ICDC fluid storage device 1100, which isillustrated with a securing device 1104 such that it can be secured tothe right atrium. A wire 404 extends from the right atrial ICDC fluidstorage device 1100 to the right ventricular ICDC device 500. A fixationdevice 100 which has been placed through the interventricular septumconnects the right ventricular ICDC device 500 to the left ventricularICDC device 500. The fixation device 100 contains the wire 404. The wire404 extends from the left ventricular ICDC device 500 to the reservoirin the left atrium. Near the end of the tube, a penetrator device 410can be included such that the device can be placed through theinterventricular septum. Alternatively, the penetrating device 410 canbe a separate piece of equipment. Note that a tube is not present inthis apparatus. A tubeless system can therefore be accomplished.

FIG. 16 illustrates an example ICDC device wherein the pressure insidethe device decreases while the ICDC is expanding. This can beaccomplished an air and apparatus filled balloon 1600 with a mechanicalvolumetric displacement device comprising a hub 1602 and spoke 1606apparatus using pistons to alter the radius of the device and driveexpansion and contraction of the device. FIG. 16A illustrates thecontraction of the balloon 1600 wherein the radius of a spokes 1606 isdecreased. During this time epoch, the pressure inside of the balloonincreases and the pressure inside of the cardiac chamber decreaseshelping with cardiac chamber filling. FIG. 16B illustrates the expansionof the balloon 1600 through increasing the radius of the spokes 1606.During this time epoch, the pressure inside of the balloon drops and thepressure inside of the cardiac chamber increases helping with cardiacchamber emptying. The central hub of the ICDC would have pistons onspokes, which would project radially outward in a sphere-like shape. Thetip of the spoke 1600 would contact the surface of the balloon 1600 andwould be designed to be round and durable.

FIG. 17 quantifies the volumetric displacement by an ICDC duringexpansion/contraction phases and internal pressure. In this example, thedifference in the volume of the ICDC from the expanded phase (volume of34 mL) to the shrunken phase (volume of 4 mL) would be approximately 30mL. The volume of compressible material (i.e., air) within materialwould be 33 mL in the expanded phase and 3 mL in the shrunken phase. Thevolume of non-compressible material within the ICDC is shown as 1 mL forboth the expanded phase and the shrunken phase. Standard pressure-volumerelationship calculations would be utilized. This illustrates that theICDC pressure would be low in the expanded phase and higher in theshrunken phase. This system using air would obviate the need formultiple fluid storage devices.

FIG. 18 illustrates a simplified system containing only a leftventricular ICDC without a reservoir. This could be placed through asingle puncture through the interventricular septum and yield a singleICDC into the left ventricle. The electrical control device 402 andbattery 400 are connected to the ICDC via a wire 404. A portion of theICDC 502 is used to secure the device to the right ventricular side ofthe interventricular septum, which is connected to another portion ofthe ICDC 100 traversing the interventricular septum and connecting tothe left ventricular ICDC balloon device 500, which is shown in greaterdetail in FIG. 16. The fixation device 100 contains the wire 404. Thewire 404 extends into the left ventricular ICDC device 500 to thereservoir in the left atrium. A penetrator device 410 can be includedsuch that the device can be placed through the interventricular septum.Alternatively, the penetrating device 410 can be a separate piece ofequipment. Note that both a tube and reservoir are not present in thisapparatus, which highlights the flexibility of this system.

What is claimed is:
 1. A method comprising: placing a balloon within achamber of a heart wherein said balloon encloses a mechanical expansiondevice wherein said placing said balloon comprises at least one of thegroup consisting of: creating a hole in an atrial septum for placement;and creating a hole in a ventricular septum for placement; during afirst time epoch in which said chamber is volumetrically contracting,increasing a size of said mechanical expansion device to cause saidballoon to increase in size; and during a second time epoch in whichsaid chamber is volumetrically expanding, decreasing a size of saidmechanical expansion device to cause said balloon to decrease in size.2. The method of claim 1 further comprising wherein said chambercomprises an atrium.
 3. The method of claim 1 further comprising whereinsaid chamber comprises a ventricle.
 4. The method of claim 1 furthercomprising wherein said balloon is secured to an atrial septum.
 5. Themethod of claim 1 further comprising wherein said balloon is secured toa ventricular septum.
 6. The method of claim 1 further comprisingiterating volumetric expansion and volumetric contraction of saidballoon in synchronization with sensed timing of the heart.
 7. Themethod of claim 1 further comprising iterating volumetric expansion andvolumetric contraction of said balloon in synchronization withelectrical pulses delivered to said chamber of said heart by at leastone electrode.
 8. The method of claim 1 further comprising iteratingvolumetric expansion and volumetric contraction of said balloon inresponse to a controller.
 9. The method of claim 1 further comprisingiterating volumetric expansion and volumetric contraction of saidballoon in response to patient activity level.
 10. The method of claim 1further comprising configuring said mechanical expansion device to causesaid balloon to expand to a pre-determined level.
 11. The method ofclaim 1 further comprising configuring said mechanical expansion deviceto cause said balloon to contract to a pre-determined level.
 12. Themethod of claim 1 further comprising configuring said balloon based onechocardiogram data.
 13. The method of claim 1 further comprisingplacing at least one additional balloon in at least one additionalchamber.
 14. The method of claim 1 further comprising modifyingvolumetric expansion and volumetric contraction of said balloon inresponse to an arrhythmia.
 15. An apparatus comprising: a balloonadapted to be enclosed within a chamber of a heart wherein said balloonencloses a mechanical expansion device wherein said balloon is adaptedto be placed by creating in a hole in an atrial septum or a ventricularseptum and wherein: during a first time epoch in which said chamber isvolumetrically contracting, increasing a size of said mechanicalexpansion device to cause said balloon to increase in size; and during asecond time epoch in which said chamber is volumetrically expanding,decreasing a size of said mechanical expansion device to cause saidballoon to decrease in size.
 16. The method of claim 15 furthercomprising wherein said chamber comprises at least one of the groupconsisting of: an atrium; and a ventricle.
 17. An apparatus comprising:a control system; a mechanical expansion device; and a balloon adaptedto be enclosed within a chamber of a heart wherein said balloon enclosessaid mechanical expansion device wherein said balloon is adapted to beplaced by creating a hole in an atrial septum or a ventricular septumand wherein: during a first time epoch in which said chamber iscontracting, increasing a size of said mechanical expansion device tocause said balloon to increase in size; and during a second time epochin which said chamber is expanding, decreasing a size of said mechanicalexpansion device to cause said balloon to decrease in size.
 18. Themethod of claim 17 further comprising wherein said controller controlssaid size of said mechanical expansion device during said first timeepoch and said size of said mechanical expansion device during saidsecond time epoch.